Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement

2021 ◽  
pp. OP.20.00821
Author(s):  
Dax Kurbegov ◽  
Patricia Hurley ◽  
David M. Waterhouse ◽  
Nicholas J. Robert ◽  
Grzegorz S. Nowakowski ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Task Force ◽  
Trial Site ◽  
Novel Treatments ◽  
Research Organizations ◽  
Start Up ◽  
Clinical Trial Site ◽  
Oncology Clinical Trials ◽  
Timely Access ◽  
More Trial

PURPOSE: Feasibility assessments (FAs) are important to establish site capabilities to conduct clinical trials and their suitability for specific trials. However, current FA methods used by biotechnology and pharmaceutical (biotech-pharma) trial sponsors and contract research organizations (CROs) are costly, inefficient, unnecessarily burdensome, and resource intensive. These methods delay trial start-up, act as a barrier to site participation, and ultimately reduce timely patient access to clinical trials and novel treatments. METHODS: An ASCO Task Force was convened to assess the specific burdens and challenges with FAs and to develop recommendations to improve their efficiencies and effectiveness. Stakeholders (including trial sites, biotech-pharma sponsors, and CROs) provided insights into challenges and offered solutions through two surveys and an in-person meeting. The Task Force used the feedback to formulate consensus recommendations to improve FAs for oncology clinical trials. RESULTS: Three key recommendations were identified for application across all biotech-pharma sponsored trials: (1) implement a streamlined and uniform FA process across trials and sponsors; (2) minimize and standardize questions; and (3) leverage technology to centralize FAs, facilitate communications, and reduce redundancies. CONCLUSION: There is an urgency to improve the current FA process, which is costly, inconsistent, inefficient, labor intensive, and of uncertain effectiveness. All stakeholders stand to benefit from implementing these recommendations, which aim to minimize burdens and ensure that more trial sites and patients have timely access to oncology clinical trials. To have meaningful impact, adoption and consistent execution of these recommendations across all trials, sponsors, CROs, and sites are essential.

scholarly journals AB1360-HPR A MODEL TO IMPROVE MINORITY PATIENT RECRUITMENT IN LUPUS CLINICAL TRIALS - THE AMERICAN COLLEGE OF RHEUMATOLOGY MIMICT PROJECT EXPERIENCE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1967.2-1967
Author(s):  
S. Sheikh ◽  
N. Wanty ◽  
S. Mccalla ◽  
A. Santana ◽  
S. Saxena Beem ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Women’S Health ◽  
Women's Health ◽  
Lupus Erythematosus ◽  
Self Efficacy ◽  
Trial Site ◽  
American College Of Rheumatology ◽  
Clinical Trial Site ◽  
The Us

Background:In the US, African Americans and Latinos are underrepresented in lupus clinical trials (LCTs),1despite experiencing the greatest lupus disease burden.2,3Low participation in LCTs results in inadequate data on treatment effectiveness for minority patients, and fewer opportunities for better care and treatment options.1Only one percent of minority patients are referred to clinical trials each year.4Provider barriers to making referrals include limited time and unfamiliarity with lupus and LCT opportunities.4Using US fedral grant funds, the American College of Rheumatology (ACR) developed MIMICT, a two-part model with associated materials to address provider-side LCT referral barriers. The materials include a toolkit for clinical trial sites and an educational toolkit for providers.Objectives:Our objectives are to:•Describe the US LCTs disparities.•Discuss the research methodology to evaluate the two-part MIMICT model.•Assess the feasibility of the model to increase minority involvement in clinical trials.Methods:We designed two studies to evaluate the MIMICT model.The first study used an online, pretest/posttest, two-group evaluation approach to assess the extent to which the educational toolkit increased providers‘ knowledge, attitudes, self-efficacy, and behavioral intentions to refer minority patients to clinical trial. We conducted the study in 2018 with primary care providers (PCPs) and again in 2019/2020 with speciality providers. The second study used a longitudinal, mised methods, case-study approach to explore the real-world use of the toolkits with clinical trial site teams at two university medical centers.Results:In the first study,among MIMCT-exposed PCPs, mean scores indicated statistical significance at p≤0.001 with more knowledge about referring [55.84 (sd=23.51) vs 41.76 (sd=19.98)], more self-efficacy to refer [55.00 (sd=37.22) vs. 37.99 (sd=34.42)], and more intentions to refer [61.36 (43.85) vs. 33.41 (41.16)] African American patients to LCTs among the treatment group than the control group, respectively. This presentation will discuss additional data comparing the study in 2018 and the study in 2019/2020 and look comparatively at outcomes across provider type.In the second study, we found that the driver for successful engagemetn of providers and their subsequent use of the educational toolkit was the development of a trusting relationship between the clinical trial site teams and providers in the community. The development of trust took repeated and varied modes of contact, which we will discuss in-depth.Conclusion:The MIMICT educational toolkit increase knowledge, self-efficacy, and intentions to refer lupus patients to LCTs. However, building trust between LCT sites and local providers takes time and repeated outreach, but the potential benefits to medicine and minority health are substantial.References:[1]The Society for Women’s Health Research. (2011). Dialogues on diversifying clinical trials: successful strategies for engaging women and minorities in clinical trials. Washington, DC: Food and Drug Administration, Office of Women’s Health.[2]Falasinnu, T., Chaichian, Y., Bass, M. B., & Simard, J. F. (2018). The representation of gender and race/ethnic groups in randomized clinical trials of individuals with sytemic lupus erythematosus.Current Rheumatology Reports, 20(4).[3]Pons-Estel, G. J., Alarcon, G. S., Scofield, L., Reinlib, L., & Cooper, G. S. (2010). Understanding the epidemiological progression of systemic lupus erythematosus.Seminars in Arthritis and Rheumatism, 39(4).[4]Korieth, K. (2016). Engaging healthcare providers as research facilitators.The CenterWatch Monthly, 23,1-5.Disclosure of Interests:None declared

Transforming the site feasibility assessment process for oncology clinical trials.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14092-e14092
Author(s):  
Dax Kurbegov ◽  
Patricia A. Hurley ◽  
David Michael Waterhouse ◽  
Grzegorz S. Nowakowski ◽  
Edward S. Kim
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Task Force ◽  
Assessment Process ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Contract Research Organization ◽  
Feasibility Assessment ◽  
Oncology Research ◽  
Start Up

e14092 Background: Current methods to assess trial sites for clinical trial participation are onerous, with unnecessary redundancies and no-value steps that impact research site resources and clinical trial participation. This project sought stakeholder feedback on recommendations to transform industry sponsor and contract research organization (CRO) processes for evaluating sites for trials. Methods: An ASCO task force developed recommendations to improve the feasibility assessment process and standardize and centralize questions and forms. A survey was conducted with sites, industry trial sponsors, and CROs to obtain feedback and assess buy-in for the recommendations. Results: Respondents were from 28 oncology research sites (19 academic, 9 community-based), 8 sponsors, and 4 CROs. All stakeholders agreed that the current process is burdensome (93% sites, 90% sponsors, 100% CROs), standardization will improve the process (86% sites, 87% sponsors, 75% CROs). All agreed a centralized portal will reduce burdens (93% sites, 100% sponsors, 75% CROs) and expedite trial start-up (89% sites, 100% sponsors, 75% CROs). Site certification was a viable option for sites (86%) and CROs (75%), but less so for sponsors (57%). Most respondents preferred a two-tier model: 1) a short site questionnaire followed by a pre-study visit for new interactions, and 2) only a pre-study site visit or a teleconference if there is an existing relationship. The greatest benefits were time savings, expedited start-up, reduction in personnel resources, and cost savings. The greatest barriers to adoption were buy-in and alignment from sponsors/CROs and insufficient information about site or protocol. Top predictors of a site’s success on a trial were physician engagement, available patients, and site experience. Conclusions: Site feasibility assessments are important for all stakeholders to establish trial suitability. However, current methods impose tremendous burdens on site resources (reported by authors elsewhere). While this sample is limited, the proposed process and standardization changes show promise to reduce burdens and costs for all stakeholders and expedite patient enrollment onto clinical trials.

Reducing burdens of site feasibility assessments for conducting clinical trials.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 300-300
Author(s):  
Dax Kurbegov ◽  
Patricia A. Hurley ◽  
David Michael Waterhouse ◽  
Grzegorz S. Nowakowski ◽  
Edward S. Kim
Keyword(s):  
Clinical Trials ◽  
Task Force ◽  
Treatment Options ◽  
Cost Savings ◽  
Assessment Process ◽  
High Quality ◽  
Feasibility Assessment ◽  
Start Up ◽  
Ensure Patient Safety ◽  
Prior Relationship

300 Background: Current methods to assess site feasibility for industry-funded clinical trials are onerous and delay patient access to novel treatment options and high-quality clinical trials. Industry sponsors and contract research organizations (CROs) often probe for unnecessary and/or duplicative information. These burdens prolong trial start-up times and are a barrier to site participation in oncology trials. The American Society of Clinical Oncology (ASCO) Research Community Forum convened a task force to identify ways to improve the site feasibility assessment process. Methods: Data were collected in 3 steps: 1) survey to assess site burdens, 2) collation of sample feasibility questionnaires (FQs), and 3) stakeholder meeting to discuss potential solutions. The task force then developed recommendations for process improvements and obtained stakeholder feedback through a survey. Results: 113 oncology practices (66 community, 47 academic) reported completing a median 5 FQs and 2 pre-study site visits (PSSVs) per month. FQs took a median 2 hours to complete whereas PSSVs took a median 4 hours to complete. Most considered FQ (81%) and PSSV (91%) content redundant to information previously provided, and FQs similar between different sponsors (86%). The median time from first contact to first patient enrolled was 6 months. The 40 respondents to the stakeholder survey represented 19 academic- and 9 community-based sites, 8 industry sponsors, and 4 CROs. Most preferred a model with a short FQ plus a PSSV when there was not a prior relationship. If there was a prior relationship, either a PSSV or teleconference was preferred. All stakeholders identified time savings, expedited start-up, fewer staff resources, and cost savings as the greatest benefits. The greatest barriers to adoption were buy-in from sponsors and CROs, and insufficient information about site capabilities. Conclusions: Site feasibility assessments for industry-sponsored trials are important to ensure patient safety and access to high quality clinical trials. However, current methods are inefficient and time and resource intensive. This initiative provided insights about challenges for sites and the viability of a fundamental change to site feasibility assessments. ASCO recommendations are forthcoming on improving processes, standardizing and minimizing questions, and using portals that are effective across all trials and clinical research scenarios.

scholarly journals Clinical trials site recruitment optimisation: Guidance from Clinical Trials: Impact and Quality

2021 ◽  
pp. 174077452110159
Author(s):  
Christine Zahren ◽  
Sonia Harvey ◽  
Leanne Weekes ◽  
Charlotte Bradshaw ◽  
Radhika Butala ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Best Practice ◽  
Project Team ◽  
Trial Site ◽  
Participant Recruitment ◽  
Recruitment Methods ◽  
Clinical Trial Site ◽  
Research Organisations ◽  
A Site

Background/Aims: Participants are integral to the success of any clinical research study, yet participant recruitment into clinical trials poses ongoing and complex challenges. It is widely accepted and recognised that clinical trial sites often find it difficult to meet recruitment goals, both in terms of accrual targets and timelines. This can impact the validity of trials or cause major delays for research. There are very few frameworks available to clinical trial sites to improve recruitment. The GREET project (Guidance to Recruitment: Examining Experiences at clinical Trial sites) sought to identify barriers to recruitment and produce formal guidance to optimise recruitment outcomes. Methods: Clinical Trials: Impact and Quality, a collaborative of sector stakeholders, convened a project team with comprehensive knowledge of the Australian clinical trials sector to undertake the GREET project. The project scope included exploration of recruitment issues at a site level across all phases of clinical trials and all types of trial sites. The scope excluded upstream issues such as protocol design and general public clinical trial awareness, participant retention and elements of recruitment outside a site’s capacity to directly influence or control. The project team’s extensive knowledge and experience conducting clinical trials in Australia was used to collaboratively identify a list of 24 key barriers and 12 enablers to site recruitment which formed the basis of the project. Key stakeholder groups were surveyed to challenge project team assumptions. A national and international environmental scan and literature review was conducted to identify best-practice recruitment solutions. Results: A total of 343 people responded to a survey sent to sites, sponsors, and contract research organisations, and 162 people responded to a survey sent to consumers via consumer networks. The key barriers and enablers initially identified by the project team aligned with the key outcomes of the surveys, which in turn assisted in the development of best-practice recommendations in the form of a Clinical Trial Site Recruitment Guide. Recommendations were grouped into four key themes; conducting accurate study feasibility; proactive planning during start-up; selecting optimal recruitment methods; and participant involvement. Early intervention was identified as a key facilitator in maximising improved recruitment outcomes. The GREET Clinical Trial Site Recruitment Guide is publicly accessible on the Clinical Trials: Impact and Quality website. Conclusion: Participant recruitment challenges experienced at a site level are widespread and varied, and there is no universal recruitment solution. However, this project identified that there are interventions and assessments that can be proactively implemented and selectively applied to facilitate improved recruitment outcomes.

scholarly journals A Framework and Road Map for Rapid Start-up and Completion of a COVID-19 Vaccine Trial: A Single Clinical Trial Site Experience

2022 ◽  
pp. 1-15
Author(s):  
Carlos Rojas ◽  
Stephen A. Spector ◽  
Bernadette Cale ◽  
Megan Loughran ◽  
Leander Lazaro ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vaccine Trial ◽  
Trial Site ◽  
Road Map ◽  
Start Up ◽  
Clinical Trial Site

scholarly journals How a Psychopharmacology Clinical Trial Site in the Seattle Area Managed Clinical Trials and Patient Care During the COVID-19 Pandemic

2020 ◽  
Vol 28 (9) ◽  
pp. 999-1003
Author(s):  
Shirin Schilling ◽  
Sinthuja Mohanarajah ◽  
Abraham Mengstu ◽  
Arif Khan ◽  
Walter A. Brown
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Patient Care ◽  
Trial Site ◽  
Clinical Trial Site

Improving start-up times in oncology clinical trials: An ASCO quality improvement project.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 297-297 ◽  
Author(s):  
Leslie Byatt ◽  
Kaylee Deutsch ◽  
Zoneddy R. Dayao
Keyword(s):  
Clinical Trials ◽  
Positive Impact ◽  
Improve Patient Care ◽  
Novel Therapies ◽  
Patient Access ◽  
Activation Time ◽  
Improvement Project ◽  
Start Up ◽  
Oncology Clinical Trials ◽  
Improve Patient

297 Background: With the increasing complexity of clinical trials, the UNMCCC and NMCCA are seeing increased delays in study activation. Currently, the average time from protocol receipt to trial activation is 33 weeks. Creating strategies to shorten the timeline where the longest delays occur will expedite patient access to novel therapies and improve patient care. Aims: Define the average activation timelines; Identify the timeline where an intervention will make the most impact in shortening start-up time; Implement an intervention, beginning February 2018; Identify strategies to decrease the longest timeline by 50% by December 2018. Methods: Timelines of 81 clinical trials opened in 2017 were analyzed. Data showed that the longest timeline is IRB approval to activation (12 weeks) and identified this as the focus of intervention to decrease our overall activation time by 50% (6 weeks). Two focus group meetings with involved staff were organized and completed. Interventions were identified. The time to complete activation tasks cannot be shortened due to staffing resources. However, shifting these tasks forward in our timeline could decrease the time to activation by at least 6 weeks. A sponsor survey was created to identify logistical concerns earlier. Regulatory coordinators were provided an email template to request systems access early. Site initiation visits are scheduled earlier. Results: Our data shows that our interventions have had a strong positive impact on our timelines. Conclusions: Since implementation, we have seen an improvement in our study timeline. We will continue to track and analyze our timeline data to determine if these strategies are effective across trials with varying startup complexities.[Table: see text]

Qualifying sites for oncology clinical trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6619-6619
Author(s):  
Dax Kurbegov ◽  
Edward S. Kim ◽  
Patricia A. Hurley ◽  
David Michael Waterhouse
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
No Value ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Research Organizations ◽  
Oncology Clinical Trials ◽  
Multi Stakeholder ◽  
First Contact ◽  
The Impact

6619 Background: Current methods to assess trial sites for clinical trial participation are onerous, with unnecessary redundancies and “no-value” steps that impact clinical trial participation. This project assessed the impact of current sponsor and contract research organizations (CRO) methods to evaluate sites for trials. Methods: A survey was conducted with community- and academic-based trial sites. Samples of feasibility questionnaires (FQs) used by sponsors and CROs were also compiled. An ASCO sponsored multi-stakeholder meeting was held to identify strategies to more effectively assess trial sites. Results: 113 oncology practices (63 community, 50 academic) reported completing 11 FQs and 4 pre-study site visits (PSV) on average per month. On average, each FQ took 4 hours (528 hours/site and 59,664 hours for all respondents, annually) and each PSV took 10 hours (480 hours/site and 54,240 hours for all respondents, annually) to complete. Thus, the total staff hours required to complete site feasibility assessments was 113,904 annually. Respondents reported that content in both FQs (82%) and PSVs (91%) was redundant to information previously provided and FQs were redundant between different sponsors (86%). The 42 sample FQs had a median 45 questions (range 13 to 96). Respondents noted that sponsors/CROs provided insufficient study documentation to accurately complete FQs. It took 7 months on average from first contact to first patient enrolled. Respondents also provided feedback about standardizing and streamlining site qualification processes. Conclusions: The current methods of assessing site feasibility for clinical trials poses tremendous burden on site resources and is not sustainable. New methods are needed that standardize, harmonize, and streamline criteria and site assessments. Such changes will reduce burden and costs for all stakeholders, and will expedite and increase patient enrollment onto clinical trials.

scholarly journals Criteria for site selection in industry-sponsored clinical trials: a survey among decision-makers in biopharmaceutical companies and clinical research organizations

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Tilde Dombernowsky ◽  
Merete Haedersdal ◽  
Ulrik Lassen ◽  
Simon Francis Thomsen
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Clinical Research ◽  
Site Selection ◽  
Decision Makers ◽  
Relative Importance ◽  
Related Factors ◽  
Trial Site ◽  
Large Patient ◽  
Research Organizations

Abstract Background Knowledge of what the pharmaceutical industry emphasizes when assessing trial sites during site selection is sparse. A better understanding of this issue can improve the collaboration on clinical trials and increase knowledge of how to attract and retain industry-sponsored trials. Accordingly, we investigated which site-related qualities multinational biopharmaceutical companies and clinical research organizations (CROs) find most important during site selection. Methods An online survey among decision-makers for trial site selection in the Nordic countries employed at multinational biopharmaceutical companies and CROs was conducted. The respondents’ experiences with and perceptions of site selection were addressed to evaluate the relative importance of site-related qualities. We included up to four respondents per company, representing different geographic regions. Descriptive statistics were used to summarize findings. Results Of 49 eligible companies, 20 biopharmaceutical companies and 23 CROs participated. In total, 83 responses were analyzed (estimated response rate 78%). A relative importance of site-related qualities was identified: For example, 88% (binomial 95% confidence interval [CI] ±7%) preferred reaching enrollment goals at trial sites in their region 10% quicker rather than cutting the costs at all sites by 20%. Likewise, 42% (CI ±11%) of the respondents preferred that trial sites were best at having the first patients ready for inclusion right after site initiation visit compared to having good data entry, documentation, and reporting practice (25% [CI ±9%]), easily reachable site personnel and backup (23% [CI ±9%]), fast contractual procedure times (6% [CI ±5%]), a key opinion leader associated with the site (3% [CI ±4%]), and updated equipment and facilities (1% [CI ±2%]). In total, 75% [CI ±9%] agreed that their company would be interested in cooperating with an inexperienced trial site if the site had access to a large patient population and 52% [CI ±11%] had experienced that their company selected an inexperienced trial site in favor of an experienced site due to a higher level of interest and commitment. Conclusions This study indicates that recruitment-related factors are pivotal to the pharmaceutical industry when assessing trial sites during site selection. Data quality-related factors seem highly valued especially in early phase trials whereas costs and investigator’s publication track record are less important. Experience in conducting clinical trials is not imperative. However, this applies primarily to late phase trials.

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